Table 1.
Patient baseline demographics and clinical characteristics.
| Characteristic | Elagolix + add-back therapya (n = 395) | Placebo (n = 196) |
|---|---|---|
| Age, y, mean (±SD) | 42.6 (5.3) | 42.0 (5.6) |
| Race, n (%) | n = 394b | n = 196 |
| White | 118 (29.9) | 60 (30.6) |
| Black/African American | 265 (67.3) | 133 (67.9) |
| Other | 7 (1.8) | 2 (1.0) |
| Multiple | 4 (1.0) | 1 (0.5) |
| BMI, kg/m2, mean (±SD) | 33.3 (6.9) | 33.8 (7.5) |
| Primary fibroid volume, cm3, mean (±SD) | 75.6 (112.8) | 87.7 (129.1) |
| MBL volume, mL, mean (±SD) | 233.4 (149.4) | 254.8 (175.7) |
| Uterine volume, cm3, mean (±SD) | 485.1 (384.7) | 512.4 (405.9) |
| FIGO primary fibroid classification cohort, n (%) | n = 389 | n = 192 |
| 0–3 (submucous) | 78 (20.1) | 38 (19.8) |
| 4 (intramural) | 191 (49.1) | 96 (50.0) |
| 5–8 (subserosal) | 120 (30.8) | 58 (30.2) |
Note: BMI = body mass index; FIGO = International Federation of Gynecology and Obstetrics; MBL = menstrual blood loss; SD = standard deviation.
a
Add-back therapy consisted of estradiol (1 mg) and norethindrone acetate (0.5 mg).
b
One patient in the elagolix + add-back therapy cohort was missing data on race.